As a result of this concern several entities, such as CLSI, FDA, SCCM, IFCC and ISICEM, published guidelines or recommendations with BGMS accuracy criteria aimed at reducing the risk to hospitalized patients and specifically patients in critical care settings.
Based on FDA requirements, capillary whole blood is not acceptable with any BGMS and is considered "Off-Label" in critically ill patient care settings.
The FDA now requires BGMS manufacturers to submit data to obtain labelling for use in critically ill patients inclusive of an extensive risk assessment using a range of clinical accuracy and risk assessment tools.
The Liberty(TM) BGMS incorporates dozens of proprietary technologies, conceptualized and substantiated over several years of research and development, to provide users with industry-leading, world-class accuracy for safer testing.
Other major makers of products serving the $6 billion BGMS market include Roche (LSE: ROG), Johnson and Johnson (NYSE: JNJ), Bayer (NYSE: BAY), Abbott (NYSE: ABT), and Becton Dickinson (NYSE: BDX).
The Liberty(TM) BGMS features a number of unique functions including a unit of measurement safety lock designed to prevent misinterpretation of results, a double redundant power supply for more reliable data memory, 6 user settable alarms, and both hypoglycemic and hyperglycemic alerts.